ISO 14001 EMS

ISO 9001 Standard - ISO 9001 Standards

2012-01-01T04:56:00.000-08:00

ISO 9001 Standard - ISO 9001 Standards

Sample ISO 9001 Internal Auditing Procedure

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1. PURPOSE
The purpose of this procedure is to define the steps that follows in planning, performing, reporting, recording, and following up on internal audits.
conducts internal audits to determine whether the quality management system:
- Conforms to planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by (QMS Manual policies, procedures, work instructions, and forms)
- Is effectively implemented and maintained.

2. SCOPE
This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system.

3. DEFINITIONS
None

4. REFERENCES
4.1 Quality Manual,
5. ASSOCIATED DOCUMENTS
5.1 Audit Check List,
5.2 ERC/ERO Procedure,
5.4 Audit Schedule,
5.3 Audit Notebook

6. PROCEDURE
NOTE 1: This procedure is typically initiated about four weeks prior to the execution of an internal audit as called for by ’s audit schedule. The audit schedule is established and maintained by The Quality Assurance Manager.
NOTE 2: Every element in the quality system is audited on a regular basis and at minimum of once per year. Activities are audited more frequently if there are significant changes taking place (i.e., many new hires/high turnover of personnel, modified procedures and work instructions, etc.) or if there is a history of problems in that area.
NOTE 3: Only qualified personnel may perform internal auditing activities. These qualified personnel are classified as internal auditors and have received the following training as a minimum: 1 day training on internal auditing techniques, 1 day training on the ISO 9001 Standard, this training may be performed by previously trained internal auditors.

6.1 AUDIT PLANNING, COORDINATION, AND PREPARATION
6.1.1 The Quality Assurance Manager defines the specific criteria, scope, methods, and objectives for the upcoming internal audit based on the status, maturity, and importance of specific elements in ’s quality system.
Audits shall be carried out to a defined scope and shall be as follows,
a) Planned: as per the internal audit plan
b) Unplanned: arising as a result of,
- Customer complaints
- Following the implementation of actions defined in a corrective action report
- Following the identification of additional or amended procedures for products
NOTE 4: In planning the particular audit, these activities include determining the extent and boundaries of the audit (locations, activities, processes); set of policies, procedures and/or requirements to be audited against; auditing methods; and audit objectives.
6.1.2 The Quality Assurance Manager selects the appropriate auditor to ensure objectivity and impartiality of the audit process.
6.1.3 The Quality Assurance Manager and the auditor review the proposed audit program to ensure that it is consistent with and effective for the defined audit criteria, scope, methods, and objectives.
6.1.4 Prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited.

6.2 INTERNAL QUALITY AUDIT INVESTIGATION

6.2.1 The auditor will contact the personnel in the area being audited at the time indicated on the audit program, and briefly review the audit criteria, scope, methods and objectives with them.
NOTE 5: The checklists only serve as a guide to the auditors, and other areas may be investigated as deemed necessary by the auditors or as requested by the auditee.
6.2.2 When a nonconformance is identified, the auditor presents the nature of the nonconformity and the evidence to the personnel involved for verification, clarification, and addresses any questions or concerns that the personnel may have, as well as to give advice, when requested, regarding any problems which are uncovered.
6.2.3 If the nonconformance is confirmed, then go to step 6.2.5.
6.2.4 If the possible nonconformance requires further clarification the auditor will discuss the situation with the Quality Assurance Manager.
6.2.5 After the facts of the nonconformity are verified (or modified), the auditor either drafts nonconformance statement or documents the necessary information for writing one later.
NOTE 6: The nonconformance statement includes the nature of the nonconformity, the actual evidence obtained, and the nature of the requirement that is not being complied with (i.e., the appropriate ISO 9001 clause number, the appropriate quality system document section/page/paragraph, what the personnel says is the normal practice, contract requirements, statutory regulations, current standards, and any other relevant requirements).

6.3 REPORTING AND FOLLOW-UP
6.3.1 Within 2 weeks of completing the internal audit program, the auditor prepares a brief internal audit report and submits it to The Quality Assurance Manager for review and approval.
NOTE 7: The audit report includes the audit’s criteria, scope, methods and objectives, the names and titles of the audit team members, a summary of general observations (i.e., general degree of compliance and any significant problems encountered), all statements of nonconformities, weaknesses, and/or opportunities for improvement, and verification results for follow-up activities performed during the audit.
6.3.2 The Quality Assurance Manager reviews and approves the internal audit report, and then distributes copies of the report to senior management and the personnel of the audited areas that were directly involved in the audit.
NOTE 8: Any additional comments or observations of the Quality Assurance Manager can be attached to the report, but the auditor’s observations be will not be deleted or modified by The Quality Assurance Manager.
6.3.3 The Quality Assurance Manager request a Engineering Change Request for any nonconformity listed in the Internal Audit Report and for any weaknesses and “opportunities for improvement” identified and documented.
6.3.4 The Quality Assurance Manager updates and maintains the long-range audit schedule based upon the documented results of the audit and the planned corrective and preventive actions.
6.3.5 The Quality Manager shall maintain an audit notebook detailing all internal and external audits carried out.
- Long-range audit schedule
- Internal audit program
- Completed checklists- signed and dated by each auditor
- Audit report

7. REVIEW PROCEDURE
Any suggested improvements or modifications to this procedure are to be passed on to the Quality Assurance Manager for discussion at the next Quality Review Committee meeting.

Management Review IN ISO 9001 Standard

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One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Corrective and Preventive actions

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Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) andEngineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

ISO 9000 Training DVD

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ISO 9000 Training DVD

ISO 9000 Training DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The “Introduction to ISO 9001:2008” DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

ISO 14001:2004 Training DVD

2011-08-25T08:07:00.001-07:00

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, companies can play their part in preserving our natural environment for our next generation by implementing ISO 14001:2004 Standards – Environmental Management System.

So, what is ISO 14001:2004 Standards – Environmental Management System? What is the requirement of the ISO 14001 standards? What is the content of Environmental Management System? What are the steps in implementing ISO 14001:204 Standards – Environmental Management System? You will find the answers in this “ISO 14001:2004 Standards – Environmental Management System” DVD.

The “ISO 14001:2004 Standards – Environmental Management System” DVD will elaborate in details on:

Introduction to ISO 14001:2004 Standards – Environmental Management System.
The history & origin of the standards.
Requirement of ISO 14001:2004 Standards.
Contents Of ISO 14001:2004 Standards.
ISO 14001:2004 Implementation Steps & Checklist.

No matter how simple or complex the business, each can benefit from the implementation of a management system based on ISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organizations processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm.

In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.

ISO 14001 Essential

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ISO 14001 certification deals with Environment Management System. Environmental management system of an organization can be issued by organization for the designing and implementation of an effective management system. This certification promotes the effective and efficient management in the organization. It provides various tools which are system based, cost effective, flexible and reflect the relevant information for the environment. It was originally developed to help organizations to reduce the negative aspects of the environment. With an improved environment, a company can attain better economical benefits.

There are numerous benefits which can happen like minimizing the risk of regulatory and environment liability fines, improved efficiency, reduce operating cost with minimum wastage and used resources, business with multiple locations need not register at different at every location. Most important benefits that companies have today is that more and more companies are applying these applications to get maximum benefits and to get competitive edge as well. ISO 14001 does not specify any levels of standard for environmental performance. If it is specified the levels of environmental performance then it has to be for every business unit which is not the intention for its formation. The overall objective of making ISO 14001 is to provide a framework for a holistic and strategic approach for the organizations environmental policy.

An ISO 14001 is completely voluntary and completely different concept. Its prime objective is to comply with all business legislation and continually improve the business environment performance. This application actually helps to achieve the set business targets and goals within timeframe. Two business can completely have different measures and standards but they still will be having ISO 14001 certification. An ISO consulting and training provide assistance to a business about how to get the ISO 14001 certification. They will teach you all the process to make your process standardized that complies with certification. There are various steps for the certification mentioned below:

Establishing plans, objectives and process required.
Implementation of the process.
Checking of EMS by measuring process and reporting of business.
Improving EMS further based on reporting.
Continual improvement process.

An comprehensive ISO 14001 certification is essential to bring an organization with improved long term goal achievement, a positive reputation and increasing value of a company. A good training person or registrar can make you eligible for certification and also help you to increase your company performance and reduce the costs.

ISO 14001 Standards – Control Of Forms

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ISO 14001:2004, element 4.4.5, instructs an organization to control documents required by the EMS and the standard. While some companies often try to justify not controlled forms, let’s find out if forms are the same as “documents” and if they also should be controlled.

Organizations use forms and tables within their environmental, quality, H&S and other management systems. Often, instead of preparing a traditional instruction or a procedure with all the sections, such as scope, purpose and process description, a simple form can provide this information. Frequently registrars issue companies non-conformities for their not controlled forms of their EMS.

Repeatedly I discuss this issue with my clients. Regularly I hear the same answer “Why do I need control a form?” Honestly, I do not understand this! Why should a form be treated differently from any other document? How would one know that we need a form if it is not referenced in our ISO 14001 management system? If forms are not managed by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision? Anyway, what is a form? A short review will help answering this question. If we have a list of directions telling us to:

1 – prepare 2-column table

2 – note your organization’s name in the first column

3 – put your business’s URL into the 2-nd column

There is no doubt; most of us would call this three-line direction a procedure or an instruction. So, if this is an instruction, it shall be controlled per ISO 14001 Standard.

Now, what if we were given a two-column table where the first column was titled “You enterprise name” and the second column “Internet address”. We were asked to complete the form. Easy to imagine, we would enter our company’s name and our URL in the table. It means that we interpreted this table as an “instruction”. If it walks like duck it is a duck! OK, most like a duck

This example demonstrate that our first three-line instruction in English (that obviously needs to be controlled), serves the same function, producing the same result, as our form. Therefore, the form as an instruction and “shall” be controlled as well.

I suspect that the confusion regarding forms used in ISO 14001 environmental management systems is based on the fact that forms serve two purposes. Blank forms are brief instructions written in tabular language. The same form, after being completed, becomes a record. Since records are not required to have a number, I presume this transposes on the source document – our blank table. Let’s remember this and treat our blank forms as instructions letting the documentation control process govern them. There are a couple of easy tests you may take when you are tempted to use a form that has not been identified:

- If you created a form for ISO 14001:2004 EMS and found it was changed, would you like to know who did it and why?

- If you revised one of your ISO 14001 forms, would you like your users use the latest revision?

- If you are in Brazil on a business trip, would you like other employees to know where to find your form in your EMS?

If you answered, “yes” at least once, your form is a definite candidate for being a part of your formal ISO 14001 documentation management system.

ISO Certification – A Standard For a Quality Business

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ISO certification is accepted as the worldwide stamp of approval for business wanting to demonstrate compliance to quality systems. It is an organization working across 161 countries around the world looking to established standards for quality of materials, products, process, etc. It provided unique identification and goodwill to the organization to conduct business with any other, to deal in a global market.

The importance of ISO certification is that it provides assurance of Quality management which gives assurance to the customers. ISO Standard assessment and certification is recognized worldwide for giving your business the competitive edge, client confidence and market place leverage.

ISO provides the necessary tools to improve and unite work force of a business to increased profit margins, work efficiency, improved accuracy and customer base right through business operations. So although the process seems daunting and time consuming, the benefits of taking the time and putting the initial hard work into certification is well worth it for the long term benefit achieved. The process also includes regular internal audits of a company, to identify any nonconformity in procedures or documentation. By this it is easy catch small errors in processes or procedures before they become costly problems.

There are many ISO Companies that provides ISO Certification, Quality management, ISO standards, ISO 9001, ISO 9000, ISO 14001, ISO 27001, ISO 17025, ohsas, ohsas 18001 etc. It helps to ensure and keep the organization focus in terms of standard and quality. This is made possible in the course of certification. The organization will be given standards to work with and other training or enlightenments. The organization is to continue to follow if it must remain in the good book of the ISO. It helps in building customers trust and confidence in the company and its products. All an all ISO certification is very important for the growth and trust of customer on the business.

Integrate ISO 14001 with Existing procedures

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Much of what an organization must do in an ISO 14001 EMS is probably already being done. No organization can operate without some environmental programs in place. These programs may need modification to comply with the ISO 14001 standard, but they serve as a good starting point to begin construction of an ISO compliant EMS. In fact, a good way to look at your EMS Manual is to view it as a road map. It will tell people where to find programs the organization uses to handle environmental concerns such as: wastewater systems operational manuals, air permit operating requirements, hazardous wastes handling procedures, materials purchasing requirements, and so forth.

A well-conceived ISO 14001 EMS will use existing environmental programs and procedures as a foundation. It will also include the business management practices of the company wherever possible. An example of this would be tying environmental impacts of raw materials purchases into an existing procedure to review raw materials specifications for engineering requirements and consistency. Many firms already have such procedures in place.

Other types of program integration may include integrating cost accounting practices with environmental operational practices. Many organizations cannot actually determine where their environmental dollars go. As a result, they cannot identify opportunities for financial improvement in environmental practices. Without such information, the environmental management of an organization is difficult. If management cannot see any cost benefit in environmental decision making, the managers usually take the least costly option. Activitybased costing allows a more comprehensive understanding of how environmental expenses are accrued by process and product rather than by facility or region. Then process control and product design can be reviewed to see if costs associated with their environmental impacts can be minimized. This is a good example of what ISO 14001 hopes to accomplish–good financial management leading to better environmental control.

Initial Review Of Gap Analysis In ISO 14001

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A fundamental concept of the ISO 14001 EMS Standard is continual improvement of environmental performance. Before you can plan for improvement, you must first determine the current state of the organization’s environmental programs.

The initial review or gap analysis is, in itself, a microcosm of a well-organized approach to the entire ISO 14001 EMS development process. Each specification of the standard must be reviewed, including policy, legal requirements, training, objectives and targets, operational control systems, document control, auditing, management review, and corrective action.

The review should take into account the culture, products, marketing strategies, and other specifics of the organization. In all cases, consideration should be given to the full range of operating conditions, including possible incidents and emergency situations that may be encountered.

The ability of suppliers and subcontractors to comply with the Organization’s EMS program and applicable regulatory requirements should also be evaluated. It is strongly recommended that the initial review consider energy use, financial accounting, and information systems so that these issues may be integrated into the EMS program.

To effectively begin the Initial Review, several things must happen. First, Management should issue a company-wide announcement of intent and endorsement. This should include estimates of the time required to complete the Initial Review, and time required to complete the entire project. Second, the project leader should be identified and vested with ample authority for completion of the project.

The Initial Review is a review of all pertinent documents, from which an accurate plan is designed for the EMS Gap Analysis.

All information from the review, including deviation from regulatory requirements and adverse impacts on the environment, should be identified along with policies, programs, procedures, training and work instructions, and operational controls.

A portion of the project team should begin to assemble a registry of appropriate regulations identified during the Initial Review. All pertinent national, state, local and self-subscribed requirements should be assembled. They should be compared with identified environmental impacts.

An Initial Review is also important in ensuring that EMS design is compatible with all current organizational management structures and operations wherever possible. This is especially important where the EMS interfaces with the site’s existing health and safety, accounting, computer systems, purchasing, energy utilization and other management programs. The focus will be to achieve operational efficiencies that ensure environmental improvements and maximize cost reductions.

Initial Review outputs will be:

· An EMS Gap Analysis Design that details where existing environmental management procedures must be further investigated to determine conformance with the Standard.

· A review of the site’s overall environmental management strengths/weaknesses.

· A schedule of events for the Gap Analysis.

The gap analysis allows for a quick but comprehensive assessment of the facility’s existing environmental management practices and procedures, and compares them

with the requirements of the Standard. To perform the Gap Analysis, a standard template tailored for that specific purpose is used. The template is a questionnaire with a three way scoring system, which develops a final rating of the current programs of the site as they compare with the sections of the Standard. The score from this questionnaire and investigative template identifies which areas of the EMS might be enhanced to improve environmental performance and comply with the Standard.

Based on the results of the Gap Analysis, the project schedule and design may require modifications. Modification should precede further systems development. Using the results of the Gap Analysis, the EMS developmental process can now begin.

This may involve modifying existing procedures, adapting other business procedures such as those designed for health and safety, accounting, or risk management to environmental utilization. At certain points, new procedures will be required.

Prior to embarking on EMS development, always remember that the more flexible your EMS is, the easier it will be to implement and the more flexible it will be in the future.

ISO 9000 Standards Certification and Registration

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The International Standards Organization is responsible for two major sets of requirements that relate to an overall quality management system to be used by businesses. The ISO 9000 family of standards is the primary set of requirements for most businesses.

Quality management by definition address that the organization does certain things to “fulfill the customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives”.
ISO 14000 address the environmental management to minimize harmful effects to the environment. Again, it is a quality management system designed to “achieve continual improvement of its environmental performance.

ISO certification 9000 is the most common. So, let’s take a look at what ISO certification entails and what it means. To become certified, a quality management system must be in place that meets the requirements of the ISO standard. This begins with the business recognizes the requirements and developing a quality system to meet their needs at the same time they meet the requirements.

ISO 9000 certification and ISO 9000 registration are two different entities, though they are often used interchangeably. To achieve ISO certification 9001 , an independent registrar is hired to audit the quality system for thoroughness and compliance to all the standards. When this is accomplished, the business is offered a certificate stating that the quality system conforms to standards within the particular standard.

ISO registration means that the certification has been recorded in its client register. Because most companies have been certified and in turn registered, the terms are offed interchanged in general use. While the term “certification” is the most widely used, “registration” used in North America. Both are completely acceptable, because the business has fulfilled the requirements set forth by ISO.

ISO 9000 Document Management Software System

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Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

Why Is ISO 9001 Standards Important?

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Industrialization has completely gone under a drastic change with the growling levels of development. With the advancement in technology, there is huge competition between major players. Thus, to stand up with such high competition and developments, all sectors must produce apt services and products according to the needs of the consumers.

This could be just that the quality management system intends continual development in the company beginning from the purchasing department, design, marketing, production, and various other departments in order to provide the best of services and products, which is harmless to both the consumers as well as the environment.

To maintain the quality standards, one needs to get International Organization for Standards (ISO) that symbolizes the quality management standard at international standards. For every company, which deals in facilitating any type of services and goods, it is very important to get certified from ISO 9001:2008.

ISO 9000 is a group of standards for the quality management system and is managed or administered by the certification and accreditation bodies. Few of the requirements in the ISO 9001, one of the standards from the group or family of ISO 9000 include:

A set of methods, which covers all the main and essential processes in the industry
Monitoring each and every process to make sure that it is effective
Maintaining adequate records
Checking all outputs for any kind of defects with corrective and appropriate action where required
Regularly reviewing individual procedures and quality system as well for its effectiveness
Last but not the least, facilitating continual improvement

An organization or company, which has been autonomously certified and audited to be in conformity with the ISO 9001:2008, might publicly state that it is certified with International Organization for Standards 9001:2008 or ISO 9001:2008 registered. Nevertheless, certification with ISO 9001:2008 standards does not ensure conformity and thus the quality of end services and products, to a certain extent certifies that reliable and dependable business procedures are being applied.

Besides, to get the ISO 9001:2008 certifications, one is required to accomplish various obligations of quality control. Few of the vital clauses that must be put up to avail the ISO 9001:2008 include knowledge, range, expressions, identifications, resource management, conscientiousness, analysis, product recognition and measurement. To avail the international standards for organization 9001 certificates, one can easily get them from several certificate providers.

The providers provide the certificate once they have carefully analyzed the production and various other production departments that include quality control standards. In addition, ISO 9001:2008 is offered only when the parent company is pleased and convinced with the output. Hence, for those individuals or businesses that are looking forward to seek ISO 9001:2008 certificates, they must make sure that they fulfill all the required industrial norms.

The practice of ISO 9001:2008 for successful operation and improved customer contentment shows the way to retention of the services and goods for a longer period. With the application of ISO 9001:2008, one can also experience decreased audits and improved marketing. ISO 9001:2008 assists in endorsing international deals, revenue that directs to worker enthusiasm and self-esteem inoculation of types.

For more information on ISO 9001 Standards, kindly visit http://www.iso9001store.com

Quality Product By ISO 9001 Certification

2011-02-01T05:39:00.000-08:00

The International Organization for Standardization (abbreviated to ISO) conducts standards for institutes which are organized in more than 159 countries across the globe. The ISO has its head office in Geneva, Switzerland. In simple terms ISO certification is given to an organization in order to indicate that the organization has good standards and it is working well with its employees and its customers. The International Organization for Standardization is not a Government organization. It acts as a bridge in between the private and the public sector and brings out good standards for many organizations across a variety of industries.

There are many standards that are released by the ISO. One of the standards is the ISO 9001 certification. The reason why an organization may require the ISO 9001 certification is to ensure that the company has a very good quality management system in place and can then confirm this to their customers. Also, if an organization has ISO 9001 certification it can ensure to its suppliers that it is following a good standard regarding it’s quality management system. The main two reasons for going for the ISO 9001 certification are to show how effective a company’s production is as well as helping to give good recognition for other new markets concerning their company standards.

The main aspects of ISO 9001 certification are maintaining good quality of products and also to maintain low cost and high efficiency for the production process. The primary thing that is checked with ISO 9001 certification is to confirm that the quality goals that are set out in the company’s quality management system are met. It is also important that once a company gets its ISO 9001 certification they should be seeking to improve all the time. There should be an increase in productivity as well. The goals of ISO 9001 certification are to increase the efficiency, increase the revenue, establish proper decision making, achieve good supplier relationships and prepare documentation work about the company plans, a regular improvement process should be in place and on the whole a complete customer satisfaction system should be implemented.

The ISO 9001:2008 certifications have a few revised benefits and let us see a few of them in detail. The goals of the ISO 9001 are the same for all year where as a few enhancements will be added for every year. Likewise the ISO 9001:2008 certification’s benefits include cost reduction in the production of goods, greater customer satisfaction, improved product efficiency and improved productivity, reduction in the scrap and waste products. The aim is to prepare a quality product which passes the goals of the quality management system. The ISO 9001 certification itself should result in the reduction of customer claims, a proper delivery to the customer on time, providing great reliability, safety and quality to the products. So on the whole the ISO 9001 certification has many good policies for the organization and they are also ensuring that the quality of the product should be good, efficient and cost effective, with an increase in the productivity.

Kindly visit http://www.iso9001store.com for more information.

The Audit Plan In ISO 14001

2010-12-29T05:28:00.000-08:00

The audit plan is the document that establishes the scope, objectives and criteria, and schedule of the audit. It also goes into specific details on what areas will be audited, when, and by whom.

Other details such as which checklists may be used, how the report is to be formatted and distributed, and how meetings will be conducted can also be included in the plan. In essence, the audit plan reflects the programs, procedures, and methodologies of the EMS audit process, in accordance with element 4.5.4 of ISO 14001. These planning items are usually described in the procedures for element 4.5.4 and do not need to be re-created every time an audit occurs. For example, it can be determined that the entire EMS will be audited once per year, but in four partial events. This schedule then becomes part of the procedure.

The audit scope defines what part of the organization will be audited. Obviously, this should coincide with the scope of the EMS itself, and is usually the site in question. If the full EMS audit is divided in smaller segments conducted throughout the year, then the scope of any given segment is what portion of the organization will be audited at that time. Typically, an organization will create a chart or matrix showing the various divisions of the site or activity and when it will be audited. A typical entry may show the maintenance department being audited in the first quarter and production in the fourth quarter, for example.

Also noted in the audit plan is the audit objective(s). The audit objective describes why an audit is being conducted. Typically the reason is to conform to ISO 14001 4.5.4 requiring that the EMS be periodically evaluated. Another reason is demonstrate conformance to others.

Although EMS audits may appear in their own right to be “good practice”, it is essential that auditors have a clear concept of what the general objectives of such audits are.

The definition of EMS audits highlights the need to confirm conformance with planned arrangements and to ensure that these arrangements are effective and suitable to achieve objectives. ISO 14011 expands this to form a number of general objectives for any type of EMS audit. Audits should be carried out to:

- determine conformance of an auditee’s EMS with the EMS audit criteria

- determine whether the auditee’s EMS has been properly implemented and maintained

- to identify areas of potential improvement in the auditee’s EMS

- assess the ability of the internal management review process to ensure the continuing suitability and effectiveness of the EMS

- evaluate the EMS of an organization where there is a desire to establish a contractual relationship, such as with a potential supplier or a joint-venture partner.

Using this definition and sources such as ISO 14010 and 14011, the following statement of the specific objectives of an internal EMS audit has been developed. Internal audits should be carried out to ensure that:

- The EMS continues to meet the needs of the business

- The necessary documented procedures that exist are practical and satisfy any specified requirements

- The necessary documented procedures are understood and followed by appropriately trained personnel

- Areas of conformity and nonconformity with respect to implementation of the EMS system are identified and corrective action implemented

- The effectiveness of the system in meeting the EMS objectives is determined and that a basis is created for identifying opportunities and initiating actions to improve the EMS system

The above objectives imply that internal audits are concerned with more than just the policing of an established system. If auditors and managers are to remain committed to the implementation of the EMS system, it must also contribute to the process of developing that system and seeking improvements.

Internal auditing must not be carried out in a way that results in the transfer of responsibility from the operating staff to the auditor or auditing organization, i.e., at all times the individual or department must retain and accept responsibility for his or her role in the EMS.

If the internal audit process is not designed and implemented to meet the objectives and to avoid the pitfalls described above, it is unlikely that the top management commitment essential to an effective audit process will be readily forthcoming.

The audit criteria define what the “rules” are. For the sake of this guide, the criteria will be the elements of ISO 14001. A subtle point to note however is that the site’s EMS requirements are also part of the criteria. This means that in addition to responding to the requirements of ISO 14001, the EMS must also respond to “planned arrangements”, or what the organization said it was going to do. In audits, a common response is “the standard does not require such and such detail”. However, if the site’s procedure does require some specific response, then it becomes part of the criteria. In essence, the auditors are verifying the system not only to ISO 14001, but also to what the EMS documentation states.

How the audit is divided and scheduled throughout the time interval is up to the organization and will be a function of minimizing disruption to site operations and resource needs. The only requirement is that the full audit be completed within the frequency established in the procedures under 14001, 4.5.4. One of the requirements regarding frequency is that how often an area is audited be in part a function of prior audit results. This means that the planned frequency may change with time based on what auditors are finding.

How long each audit takes again is a function of resource needs and operations. It is recommended, however, that any individual audit event not be protracted out over long time periods. The longer a task takes, the easier it is to get distracted and lose focus.

Much has been written about how to audit a system if the full audit is not completed in one event. Unlike other audits, including quality audits, where a more segmented approach can be taken, ISO 14001 systems tend to be very sensitive to consistency. For example, the emergency planning process may conform to the standard element 4.4.7 in that a procedure exists; however,

it may not reflect the potential significant impacts identified in element 4.3.1. Had the audit team focused only on element 4.4.7, they would not have noted the apparent nonconformance.

When developing an audit plan, it is wise to consider the three C’s of ISO 14001 EMS auditing:

Conformance, Consistency, and Continual Improvement. Conformance relates to addressing each of the requirements of the standard, i.e., the “shalls”. Consistency relates to how well each procedure or process of the EMS relates to the others. In other words, do objectives and targets reflect the policy commitments? Are personnel trained on the correct legal and other requirements? Finally, Continual Improvement requires that the system lead to improvements in the system itself as well as with environmental performance. A system that has all the prerequisite procedures, but remains static, is not in conformance.

The concepts of consistency and continual improvement are more subtle because they are through-running threads of the standard and not always a definitive statement. The required commitment to continual improvement and the text of the standard itself however do go some way towards reminding the auditor.

With the three C’s in mind, one now sees why it is best to audit all applicable elements of the standard in a given area at one time, rather that tracing any one standard element throughout various areas. For example, during the first quarter audit event, Company X may audit all of ISO 14001 in maintenance. During the second quarter event, all of ISO 14001 will be audited in the production area, and so on. This is in contrast to auditing only a certain element, i.e., corrective action, across several site areas in one audit event.

Now we know what is being audited, when it is being audited, and to what “rules” it is being audited. The remainder of the plan is simply then the logistics of the audit. The logistics include identification of team members, noting if and what checklists will be used, schedule and formats of meeting to name a few. Below is the full list of recommended audit plan elements as described in ISO 14011:

• the audit objectives and scope;

• the audit criteria;

• identification of the auditee’s organizational and functional units to be audited;

• identification of the functions and/or individuals within the auditee’s organization having significant direct responsibilities regarding the auditee’s EMS;

• identification of those elements of the auditee’s EMS that are of high audit priority;

• the procedures for auditing the auditee’s EMS elements as appropriate for the auditee’s organization;

• the working and reporting languages of the audit;

• identification of reference documents;

• the expected time and duration for major audit activities;

• the dates and places where the audit is to be conducted;

• identification of audit team members;

• the schedule of meetings to be held with the auditee’s management;

• confidentiality requirements;

• report content and format, expected date of issue and distribution of the audit report;

• document retention requirements.

If the internal audit is to proceed smoothly, it is helpful for the internal auditor to establish a dialogue prior to the actual audit with the person responsible for the area being audited. This dialogue may be conducted by memo, telephone, or during a formal or informal meeting. The main factor that should influence the auditor’s choice of method for setting up this dialogue should be the organization’s normal style or culture. Irrespective of the method of communication the auditor adopts, the following points should be established:

• The overall duration of the proposed audit

• The starting location and time

• The proposed scope and areas to be covered by the audit

• A timetable for approximate progress of the audit where applicable, e.g., if a number of different departments or geographical areas are to be included in the scope of the audit

• The arrangements for any close out meeting where the findings of the audit can be agreed and corrective action requirements discussed

• The personnel liable to be involved at each stage of the audit

If an auditor does not give sufficient attention to ensuring that clear agreement is reached with respect to the above points, the potential for misunderstandings that can affect the conduct of the audit is greatly increased. However, these initial communications with the personnel of the area being audited not only affect the “tone” of the forthcoming audit, but they can significantly influence the commitment and level of cooperation shown by that area throughout the audit process and for many subsequent audits.

Prior to commencing the audit, but once the plan is prepared, the audit team assignments are made, and working documents are defined. Working documents are those documents such as observation logs and checklists that are used during the audit to collect evidence, but are not necessarily retained as records. In other words, they may be discarded after the audit is complete and the report prepared.

Of these, only the checklist should require an input at this stage from the auditor. However, before compiling a checklist, the auditor must determine if the function and format of the checklist are prescribed by the audit procedure or whether personal preference can be exercised.

The format of the checklist may vary considerably, depending on whether it is intended to act as an aide or as a part of audit records showing the scope and conduct of the audit. The former may consist only of general topics to be covered during the audit, whereas the latter may be an extensive and detailed questionnaire on which details of sampling and answers to the questions are to be recorded.

The need for checklists and the type appropriate will vary according to other experience of the auditors and the culture of the company. It is recommended that for purposes of internal audits, checklists, even if limited, should always be developed. However, standard questionnaire type checklists not prepared by the auditor that must be slavishly followed and completed, should be

avoided. This latter type is likely to result in an unnecessary restriction in the scope of the audit and a stifling of auditor initiative.

Although an auditor should always work within the scope defined for the audit, the working documents must not be designed so that they restrict additional audit activities or investigations that may become necessary as a result of information gained during the audit. There are differences of opinion over whether it is preferable to create the checklist anew or whether a previously developed checklist can be used. Although the former is desirable in principle, it is not always practical in terms of the best use of the resources available. The best compromise is to utilize whatever available checklists are already in existence, but to review these critically

against the relevant documents previously identified. In this way, time can be saved in using them as a foundation without detracting from effectiveness.

ISO 9001 Standard Quality Manual Template

2010-10-17T05:47:00.001-07:00

ISO 9001 Standard Quality Manual Template

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

Why do organizations implement ISO 9000 systems?

2010-10-17T05:46:00.001-07:00

Why do organizations implement ISO 9000 systems?

More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.

Role of Governments in ISO 14001 Standards

2010-10-17T05:45:00.001-07:00

Role of Governments in ISO 14001 Standards

Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop the
basic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:
(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and
(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certification
services. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.

Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.

ISO 9000 Softwares

2010-10-17T05:44:00.000-07:00

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Softwarewere designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.

ISO 14001 – Application to Small and Medium Size Enterprises

2010-08-17T06:19:00.001-07:00

ISO 14001 – Application to Small and Medium Size Enterprises

Most of the development and application of EMS has taken place in large companies. The use of such systems in small and medium-size enterprises (SMEs) has been limited—although it is in this segment of industry that some of the largest benefits might be anticipated, because of the difficulty of regulating large numbers of small firms and the potential efficiency improvements that are believed to exist. In practice, however, the characteristics of the typical SME make the adoption of EMS difficult: most SMEs do not have a formal management structure, they lack technically trained personnel, and they are subject to severe short-term pressures on cash flow.

Anecdotal evidence indicates that an EMS cannot be used to drive improved performance in a poorly organized SME. Targeted training in management and quality control can improve overall performance, including its environmental aspects, and can provide a basis for more specific EMS development. Many firms can reap significant benefits from introducing quality management concepts, even where they are not aiming at formal certification. Any steps in this direction should be encouraged.

An EMS, as normally envisaged, builds on existing production and quality management systems. Where such systems are weak or ineffective, as is often the case in enterprises that have poor environmental performance, a better management framework has to be established before focusing on the details of the EMS. The costs of establishing an EMS will therefore obviously depend on the starting point in terms of both management systems and environmental performance.

The ecoefficiency savings can, in some cases, pay for the costs of establishing the EMS, particularly if most of the planning and organizational work is carried out in-house. However, a poor performer will very likely have to invest in production upgrading or pollution control in order to meet environmental requirements, and these costs can be significant.

A full EMS can be complex and can require an appreciable commitment of operational resources.

However, the final system can be reached reasonably through a series of discrete steps, starting from a basic, simple procedure and becoming more comprehensive and sophisticated as capabilities and resources allow. In this way, even a small enterprise can begin to put in place the basic elements of an ISO 14001 system and can develop them at an appropriate pace. Once the basic EMS is in place, it is possible to carry out a gap analysis and to make a balanced judgment on the costs and benefits of seeking certification.

A related issue is the coverage of the EMS. Certification is normally for specific sites or facilities.

A large enterprise may have a number of different sites and production facilities and may choose to seek certification only for a subset of the sites.

Role of Governments In ISO 14001 Standards

2010-08-17T06:17:00.000-07:00

Role of Governments In ISO 14001 Standards

Although ISO 14000 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop the basic capabilities to adopt ISO 14000. There are two particular areas in which government action would be useful: (a) providing information on the sectors and markets where ISO 14001 certification is a significant issue and assisting sector organizations to develop appropriate responses, and (b) helping to establish a certification framework, based on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certification services. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.

The characteristics of quality Classification of products and services

2010-08-17T06:16:00.000-07:00

If we group products and services (entities) by type, category, class and grade

we can use the subdivision to make comparisons on an equitable basis. But

when we compare entities we must be careful not to claim one is of better

quality than the other unless they are of the same grade. Entities of the same

type have at least one attribute in common. Entities of the same grade have

been designed for the same functional use and therefore comparisons are valid.

Comparisons on quality between entities of different grades, classes, categories

or types are invalid because they have been designed for a different use or

purpose.

Let us look at some examples to illustrate the point. Food is a type of entity.

Transport is another entity. Putting aside the fact that in the food industry the

terms class and grade are used to denote the condition of post-production

product, comparisons between types is like comparing fruit and trucks – there

are no common attributes. Comparisons between categories are like comparing

fruit and vegetables. Comparisons between classes are like comparing apples

and oranges. Comparisons between grades is like comparing eating apples and

cooking apples.

Now let us take another example. Transport is a type of entity. There are

different categories of transport such as airliners, ships, automobiles and trains;

they are all modes of transport but each has many different attributes.

Differences between categories of transport are therefore differences in modes of

transport. Within each category there are differences in class. For manufactured

products, differences between classes imply differences in purpose. Luxury cars,

large family cars, small family cars, vans, trucks, four-wheel drive vehicles etc.

fall within the same category of transport but each was designed for a different

purpose. Family cars are in a different class to luxury cars; they were not

designed for the same purpose. It is therefore inappropriate to compare a

Cadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo.

Entities designed for the same purpose but having different specifications are

of different grades. A Ford Mondeo GTX is a different grade to a Mondeo LX.

They were both designed for the same purpose but differ in their performance

and features.

Now let us take an example from the service industry: accommodation. There

are various categories, such as rented, leased and purchased. In the rented

category there are hotels, inns, guesthouses, apartments etc. It would be inappropriate

to compare hotels with guesthouses or apartments with inns. They are

each in a different class. Hotels are a class of accommodation within which are

grades such as 5 star, 4 star, 3 star etc., indicating the facilities offered.

You can legitimately compare the quality of entities if comparing entities of

the same grade. If a low-grade service meets the needs for which it was

designed, it is of the requisite quality. If a high-grade product or service fails to

meet the requirements for which it was designed, it is of poor quality,

regardless of it still meeting the requirements for the lower grade. There is a

market for such differences in products and services but should customer

expectations change then what was once acceptable for a particular grade may

no longer be acceptable and regrading may have to occur.

Where manufacturing processes are prone to uncontrollable variation it is

not uncommon to grade products as a method of selection. The product that is

free of imperfections would be the highest grade and would therefore

command the highest price. Any product with imperfections would be

downgraded and sold at a correspondingly lower price. Examples of such

practice arise in the fruit and vegetables trade and the ceramics, glass and

textile industries. In the electronic component industry, grading is a common

practice to select devices that operate between certain temperature ranges. In

ideal conditions all devices would meet the higher specification but due to

manufacturing variation only a few may actually reach full performance. The

remainder of the devices has a degraded performance but still offer all the

functions of the top-grade component at lower temperatures. To say that these

differences are not differences in quality would be misleading, because the

products were all designed to fulfil the higher specification. As there is a

market for such products it is expedient to exploit it. There is a range over

which product quality can vary and still create satisfied customers. Outside the

lower end of this range the product is considered to be of poor quality.

The Characteristics Of Quality Classification